Quality Control Specialist

The Quality Control Specialist supports the manufacturing of radiopharmaceutical products by performing chemistry manipulations in a GMP environment, executing analytical testing, and ensuring regulatory compliance throughout the production process. This role focuses on process manufacturing, preparation of production materials and supplies, maintenance of general production equipment, and active participation in quality systems to help deliver safe, compliant, and reliable radiopharmaceutical products.

The Quality Control Specialist supports the manufacturing of radiopharmaceutical products by performing chemistry manipulations in a GMP environment, executing analytical testing, and ensuring regulatory compliance throughout the production process. This role focuses on process manufacturing, preparation of production materials and supplies, maintenance of general production equipment, and active participation in quality systems to help deliver safe, compliant, and reliable radiopharmaceutical products.

• Carry out production responsibilities to meet established manufacturing schedules and ensure on-time delivery of radiopharmaceutical products.
• Perform chemistry manipulations and related laboratory activities in a GMP environment to support radiopharmaceutical production.
• Ensure regulatory compliance of production protocols within manufacturing operations and adhere to applicable quality and safety standards.
• Execute analytical methods and procedures for testing GMP-manufactured radiopharmaceutical products to verify quality and consistency.
• Prepare and submit required production, testing, and quality reports in a timely and accurate manner.
• Support and execute deviation reports, out-of-specification (OOS) investigations, root cause analyses, and corrective and preventive actions (CAPA).
• Optimize and validate methods and procedures for radiopharmaceutical products to improve efficiency, robustness, and compliance.
• Assist with creating, reviewing, and maintaining standard operating procedures (SOPs) for use in production and quality control activities.
• Assist with the preparation of regulatory submissions by providing technical data, documentation, and subject matter input.
• Assist with general laboratory cleaning, supply management, and routine maintenance of lab equipment and instrumentation.
• Assist with waste management activities, including handling and disposal of materials in accordance with safety and regulatory requirements.
• Perform other related duties as assigned to support production, quality control, and continuous improvement initiatives.

• Associates degree in chemistry, biochemistry, chemical engineering, or a related field.
• Minimum of 2 years of related experience in a pharmaceutical manufacturing environment, with preference for radiopharmaceutical experience.
• Prior experience in pharmaceuticals, preferably in a quality or production position.
• Experience in a radiopharmaceutical environment is highly desirable.
• Hands-on experience in laboratory, chemistry, or chemical engineering settings.
• Experience in radiopharmaceutical or pharmaceutical manufacturing and quality control.
• Working knowledge of GMP (Good Manufacturing Practice) requirements and their application in production and testing.
• Experience with HPLC and other laboratory instrumentation used in analytical testing.
• Familiarity with aseptic techniques and cleanroom operations.
• Experience with instrument qualification, calibration, validation, and troubleshooting of lab equipment.
• Understanding of isotopes, radioactive materials, radiation safety, and nuclear medicine or radiopharma processes.
• Strong analytical skills with the ability to interpret data and support investigations.
• Excellent communication skills, including technical writing for reports, SOPs, and documentation.
• Proficiency with computer/PC-based systems used for data entry, documentation, and reporting.
• Ability to handle responsibilities in a fast-paced manufacturing environment while maintaining accuracy and compliance.
• Demonstrated ability to work effectively as part of a team.
• Thorough understanding of project management principles as applied to manufacturing and quality activities.
• Excellent organizational skills and strong attention to detail.

• Experience working with radiopharmaceutical or nuclear medicine products.
• Exposure to cyclotron operations, radioactive materials…